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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
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SENSEONICS INC. EVERSENSE SENSOR; EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM Back to Search Results
Model Number 101967-950
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/10/2023
Event Type  malfunction  
Manufacturer Narrative
This report is being submitted retrospectively as part of an internal review.An rma was authorized but not received.Therefore, no confirmation or investigation of the complaint was possible.
 
Event Description
On september 11, 2023, senseonics was made aware of an incident where user received an early sensor replacement alert resulting in an early sensor removal.
 
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Brand Name
EVERSENSE SENSOR
Type of Device
EVERSENSE CONTINUOUS GLUCOSE MONITOR SYSTEM
Manufacturer (Section D)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20876 7005
Manufacturer (Section G)
SENSEONICS INC.
20451 seneca meadows parkway
germantown MD 20876 7005
Manufacturer Contact
vallikannu somasundaram
20451 seneca meadows parkway
germantown, MD 20876-7005
MDR Report Key18394261
MDR Text Key331509483
Report Number3009862700-2023-00968
Device Sequence Number1
Product Code QHJ
Combination Product (y/n)Y
Reporter Country CodeSP
PMA/PMN Number
P160048
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 12/26/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/24/2023
Device Model Number101967-950
Device Catalogue NumberFG-4500-50-302
Device Lot NumberWP09146
Was Device Available for Evaluation? No
Date Manufacturer Received09/11/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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